Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial

Abstract Background In recent years, an increasing number of anticancer drugs have been approved based on the results of a single-arm trial (SAT). The magnitude of the objective response rate (ORR) in SATs is important for regulatory decisions, but there has been no clear guidance specifying the deg...

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Bibliographic Details
Main Authors: Yoshihiro Oda, Mamoru Narukawa
Format: Article
Language:English
Published: BMC 2022-03-01
Series:BMC Cancer
Subjects:
Online Access:https://doi.org/10.1186/s12885-022-09383-w